PIK3CA Mutation CDx – Tissue is an FDA-approved qualitative companion diagnostic assay performed on DNA extracted from FFPE breast tissue to detect 11 mutations in exons 7, 9, and 20 of the PIK3CA gene. Completion of the PIK3CA Mutation CDx Test Request Form with provider’s signature is required for this CDx test.

Alternate Name: QIAGEN therascreen® PIK3CA RGQ PCR

Amplification of the ERBB2 gene (encoding for HER2 protein) is detected by fluorescent in
situ hybridization (FISH) in human breast and esophagogastric cancer tissue specimens.

Ki67 is a nuclear protein expressed in proliferating cells, which is detected by a primary monoclonal rabbit anti-human Ki67 antibody (clone 30-9). Ki67 expression level is determined by the percentage of appropriately stained tumor cells.

HER2 protein is detected by a primary monoclonal rabbit anti-human HER2 antibody (clone 4B5). HER2 expression level is determined by the staining pattern and percentage of invasive tumor cells, and is interpreted in accordance with CAP/ASCO Guidelines.

PR protein is detected by a primary monoclonal rabbit anti-human PR antibody (clone 1E2). PR status is determined determined by the intensity and percentage of appropriately stained tumor cells, and is interpreted in accordance with CAP/ASCO Guidelines.

ER protein is detected by a primary monoclonal rabbit anti-human ER antibody (clone SP1). ER status is determined determined by the intensity and percentage of appropriately stained tumor cells, and is interpreted in accordance with CAP/ASCO Guidelines.

Genoptix offers pathologists an advanced tool to assess breast cancer biomarker status of Estrogen Receptor (ER), Progesterone Receptor (PR), HER2, and Ki-67. This imaging-based platform enables you to assess digital whole slide images, perform algorithmic calculations, and determine biomarker status via our easy-to-use, yet secure Report Builder™ website. By collaborating with Genoptix, you can work with a premier provider of Image Analysis by immunohistochemistry (IHC) technology using high quality standards and processes. The Genoptix Report Builder enables you to easily review digital slide images, score regions of interest, and build a customized professional report.